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The Diabetes Prevention Program Outcomes Study : Our Contributions Carry On Long-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High Risk The DPP/DPPOS Research Group. Diabetes Prevention Program Outcomes Study Clinics. Sponsors.

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Diabetes prevention program outcomes study clinics

The Diabetes Prevention ProgramOutcomes Study:Our Contributions Carry OnLong-term Follow-up to A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High RiskThe DPP/DPPOS Research Group


Diabetes prevention program outcomes study clinics

Diabetes Prevention Program Outcomes Study Clinics

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Diabetes prevention program outcomes study clinics

Sponsors

  • National Institute of Diabetes & Digestive & Kidney Diseases

  • Other NIH Institutes, Offices

    • National Center on Minority Health and Health Disparities

    • National Institute of Child Health and Human Development

    • National Institute on Aging

    • National Center for Research Resources, GCRC Program

    • Office of Research on Women’s Health

    • National Eye Institute

    • National Heart Lung and Blood Institute

  • Other Federal Agencies

  • Indian Health Service

  • Centers for Disease Control and Prevention


Diabetes prevention program outcomes study clinics

Sponsors

  • American Diabetes Association

  • Industry grant support

  • Bristol-Myers Squibb

  • Additional Support

  • LifeScan, Inc

  • Lipha (Merck-Sante)


Diabetes prevention program outcomes study clinics

Study Timeline


Dpp primary goal

DPP Primary Goal

  • To prevent or delay the development of type 2 diabetes in persons with impaired glucose tolerance (IGT)


Dpp study treatment groups

DPP Study Treatment Groups

Screen (158,177 people)

Randomize (3,819 people)

Standard lifestyle teaching

Intensive

Lifestyle

(1079 people)

Placebo

(1082 people)

Metformin

(1073 people)

Troglitazone

585 people

Until 6/98


Diabetes prevention program outcomes study clinics

DPP Incidence of Diabetes

Placebo (n=1082)

Metformin (n=1073, p<0.001 vs. Placebo)

Lifestyle (n=1079, p<0.001 vs. Metformin,

p<0.001 vs. Placebo)

Risk reduction

31% by metformin

58% by lifestyle


Keys to dpp lifestyle success

Keys to DPP Lifestyle Success

Weight loss was the key to diabetes prevention

Reduction of total calories, especially fat calories

Achieving 150 minutes of activity each week


Troglitazone participants

Troglitazone Participants

  • There were fewer Troglitazone participants in DPP (n=585) than in the other groups (n~1000) since recruitment was stopped early

  • Treatment with Troglitazone only lasted for an average of 9 months and therefore the long term effects of Troglitazone on diabetes prevention are not known

  • During the brief period of Troglitazone treatment, development of diabetes was decreased by ~70% compared with Placebo


Bridge period from dpp to dppos

Bridge Period from DPP to DPPOS

Summer 2001 - Fall 2002

All participants continued their DPP treatments

Metformin participants completed medicine wash-out

January - June 2002

All DPP participants were offered a 16-session Group Lifestyle Balance Program

September 2002

Diabetes Prevention Program Outcomes Study begins


Who joined dppos

Who Joined DPPOS?

3251 DPP participants joined DPPOS

88% of the original DPP participants


Who joined dppos at insert clinic name

Who Joined DPPOS at <insert clinic name>

  • <x> DPP participants joined DPPOS

  • <x>% of the original DPP participants


Dppos goals

DPPOS Goals

Diabetes delay or prevention

Prevention of diabetes complications such as kidney, eye and nerve problems, and heart disease


Dppos treatments

DPPOS Treatments

Original Placebo group

HELP classes four times a year

Original Metformin group

Metformin 850 mg twice daily

HELP classes four times a year

Original Lifestyle group

HELP classes four times a year

Boost lifestyle classes twice a year


Diabetes prevention program outcomes study clinics

Weight Change Over Time


Diabetes prevention program outcomes study clinics

DPPOS Incidence of Diabetes


Diabetes prevention program outcomes study clinics

DPPOS Incidence of Diabetes


Diabetes prevention program outcomes study clinics

DPP vs. DPPOS Diabetes Rates


Diabetes development in dppos

Diabetes Development in DPPOS

Original Lifestyle participants continue to develop diabetes at the lower rate they developed diabetes during DPP.

Original Placebo and Metformin participants have lowered their rate of diabetes development to a similar rate as the Lifestyle group.


Dppos diabetes risk reduction

DPPOS Diabetes Risk Reduction

Delay in diabetes onset after 10 years follow-up:

4 years for Lifestyle

2 years for Metformin

The lower rate of diabetes development for lifestyle and metformin during DPP means:

Original Lifestyle participants have a 34% lower risk of diabetes compared to Placebo

Original Metformin participants have a 19% lower risk of diabetes compared to Placebo


Diabetes frequency after 10 years

Diabetes Frequency After 10 years

52% of Placebo participants have diabetes

47% of Metformin participants have diabetes

42% of Lifestyle participants have diabetes


Diabetes prevention program outcomes study clinics

Use of Anti-diabetic Medicines


Heart disease risk

Heart Disease Risk

All treatment groups have decreased blood pressure, cholesterol and triglycerides.

Lifestyle participants had the same or lower blood pressure and lipid levels over time than other participants with less use of medicines.


Dpp dppos publications

DPP/DPPOS Publications

Diabetes Prevention Program

Public Website

www. bsc.gwu.edu/dpp/pps/registry.cgi


Here s what to expect next in dppos

Here’s what to expect next in DPPOS

  • A mid-year and annual visit each year

  • Four HELP classes each year

  • A set of retinal (eye) photos in 2012


Additional dppos treatments

Additional DPPOS Treatments

  • Two BOOST campaigns each year for original Lifestyle participants.

  • Metformin participants are asked to continue to take study metformin.

  • DPP troglitazone participants will no longer have clinic visits for outcomes testing.


New outcomes measures

New Outcomes Measures

  • Cognitive (Memory) Testing

  • Physical Function Testing


Individual results summary

Individual Results Summary

  • Over the next six months, you will receive a summary of your DPP and DPPOS testing

  • DPPOS staff will review this information with you and answer your questions


Your health care

Your Health Care

  • Research is not a substitute for health care.

  • See your Primary Care Provider regularly to make personal decisions about your health care.

  • If you have diabetes, continue your regular eye exams, foot exams, etc.


Thank you for your contributions to diabetes research and prevention

Thank You for Your Contributions to Diabetes Research and Prevention

Your Contributions Carry On!


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